Cleared Traditional

K142016 - CAPRI

K142016 is an FDA 510(k) clearance for CAPRI, manufactured by K2m, Inc.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K142016 · K2m, Inc. · Orthopedic device
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Nov 2014
Decision
104d
Days
Class 2
Risk

K142016 is an FDA 510(k) clearance for the CAPRI. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on November 6, 2014 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all K2m, Inc. devices

FDA 510(k) Submission Details - K142016

510(k) Number K142016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2014
Decision Date November 06, 2014
Days to Decision 104 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 122d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQP Device Classification - Class 2, Special Controls

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MQP Spinal Vertebral Body Replacement Device

All 262
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K142016.
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AIS MODULIFT VBR SYSTEM
K142150 · Aesculap Implant System, Inc. · Oct 2014
LATERAL VBR SYSTEM
K140563 · Nu Vasive, Incorporated · Aug 2014
AIS MODULIFT VBR SYSTEM
K133802 · Aesculap Implant System, Inc. · Apr 2014